The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for 3.3mm Accessories.
Device ID | K952448 |
510k Number | K952448 |
Device Name: | 3.3MM ACCESSORIES |
Classification | Implant, Endosseous, Root-form |
Applicant | NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
Contact | Mary Edwards |
Correspondent | Mary Edwards NOBELPHARMA USA, INC. 777 OAKMONT LN. SUITE 100 Westmont, IL 60559 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-25 |
Decision Date | 1995-06-20 |